Senior CSV Engineer: MES & GxP Validation

Net2Source (N2S); Bothell (WA); On-site; USD 96,432 - 103,320; Full time

Job summary

Net2Source (N2S) is seeking a Computer System Validation Engineer to lead validation activities for GxP electronic systems in Bothell, WA. The ideal candidate will have at least 4 years of strong Computer Systems Validation experience and familiarity with Manufacturing Execution Systems.

This role is vital for ensuring compliance with industry regulations and documentation standards. A Bachelor’s degree in life sciences or a related field is mandatory, alongside excellent communication skills.

Qualifications

• 4+ years of direct experience with CSV activities.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations.
• Demonstrated success in a high-performing environment.

Responsibilities

• Lead validation activities for GxP electronic systems.
• Develop requirements and specifications for computerized systems.
• Ensure documentation aligns with internal procedures.

Skills

Strong Computer Systems Validation (CSV) experience

Familiarity with Manufacturing Execution Systems (MES)

Ability to communicate effectively

Education

Bachelor's degree in a life sciences or engineering / IT discipline

Tools

SAP

Oracle

Veeva

Job description

Net2Source (N2S) is seeking a Computer System Validation Engineer to lead validation activities for GxP electronic systems in Bothell, WA. The ideal candidate will have at least 4 years of strong Computer Systems Validation experience and familiarity with Manufacturing Execution Systems.

This role is vital for ensuring compliance with industry regulations and documentation standards. A Bachelor’s degree in life sciences or a related field is mandatory, alongside excellent communication skills.